BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    MDR report key: 3142603 · Received April 5, 2013

    Report

    Report Number
    1018233-2013-01133
    Event Type
    Injury
    Date Received
    April 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    TISSUE SCIENCE LABS.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01177.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142077 PELVISOFT ACELLULAR COLLAGEN BIOMESH FTL TISSUE SCIENCE LABS. NA 08B04-1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention AMS PERIGEE| AMS MINIARC| PELVISOFT ACELLULAR COLLAGEN BIOMESH| AMS ELEVATE